Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)

Condition(s) targeted: Herpes Simplex; HIV Infections

Intervention: Crofelemer (Drug); Acyclovir (Drug)

Phase: N/A

Status: Completed

Sponsored by: Shaman Pharmaceuticals

To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS.

Official title: Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)

Study design: Treatment, Double-Blind, Safety Study

Detailed description: This trial is a double-blind, multicenter, placebo-controlled clinical trial. Participants are randomized to topical 15% SP-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir. At presentation, patients are stratified by total lesion area within each treatment group. SP-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Acyclovir is administered by mouth each day, three times a day, until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period. The primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

Patients must have:

- AIDS, according to the CDC criteria.

- Documented recurrent (at least 1 prior episode) perineal (genital, perianal and

neighboring areas) mucocutaneous herpes simplex virus (HSV) types 1 or 2 infection in the active phase.

- Duration of current episode of recurrent HSV lesions of 3 days or less.

- Ability to read and write, must be intellectually competent, and able to understand

the purposes and risks of the study.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Active internal anal or rectal herpes.

- Inability to comply with protocol.

- Impaired renal function.

Patients with the following prior conditions are excluded:

- Prior episode of recurrent genital herpes infection with documented clinical failure

of acyclovir as a treatment regimen.

- Uncompensated hepatic, cardiac, or renal failure within 1 month of the study.

- History of hypersensitivity to acyclovir.

- Previous enrollment in this study.

1. Treatment with another medication (topical, oral, or intravenous) with known anti-HSV activity within the past 5 days.

- Systemic immunomodulatory therapy within 30 days prior to study.

- Previous treatment with SP-303.

Required:

Unchanged antiretroviral therapy for the 2 weeks prior to study.

Hosp Regional de Ponce - Area Vieja, Ponce 00731, Puerto Rico

San Juan AIDS Program, Santurce 00908, Puerto Rico

Sorra Research Ctr Inc / Med Forum, Birmingham, Alabama 35203, United States

Arizona Clinical Research Ctr Inc, Tucson, Arizona 85712, United States

Hill Top Research Ltd, Scottsdale, Arizona 85251, United States

Olive View Med Ctr, Sylmar, California 91342, United States

ViRx Inc, Palm Springs, California 92262, United States

Dermatology SVC - VAMC, Long Beach, California 90822, United States

Conant Med Ctr, San Francisco, California 94117, United States

King - Drew Med Ctr / Dept of Dermatology, Los Angeles, California 90059, United States

ViRx Inc, San Francisco, California 94109, United States

Summit Med Ctr / Adult Immunology Clinic, Oakland, California 94609, United States

Novum Inc, Washington, District of Columbia 20037, United States

Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States

Gary Richmond MD, Fort Lauderdale, Florida 33316, United States

IDC Research Initiative, Altamonte Springs, Florida 32701, United States

Dr Robert Schwartz, Fort Myers, Florida 33901, United States

Treasure Coast Infectious Disease Consultants, Vero Beach, Florida 32960, United States

Veterans Affairs Med Ctr of North Chicago, Chicago, Illinois 60064, United States

Johns Hopkins Univ / Division of Infectious Disease, Baltimore, Maryland 21205, United States

Saint Agnes Healthcare / Dept of Surgery, Baltimore, Maryland 21229, United States

Massachusetts Gen Hosp - Warren 505, Boston, Massachusetts 02114, United States

Medicine / Infectious Diseases, Minneapolis, Minnesota 55455, United States

Columbia Presbyterian Med Ctr, New York, New York 10032, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

AIDS Ctr / Saint Vincents Hosp and Med Ctr, New York, New York 10011, United States

New York Univ Med Ctr, New York, New York 10016, United States

Paddington Testing Co Inc, Philadelphia, Pennsylvania 19103, United States

N Texas Ctr for AIDS & Clin Rsch, Dallas, Texas 75219, United States

Division of Infectious Diseases / Univ of Texas - Houston, Houston, Texas 77030, United States

Austin Infectious Disease Consultants, Austin, Texas 78705, United States

Dr Robert Holman, Arlington, Virginia 22205, United States

Novum Inc, Seattle, Washington 98122, United States

Univ of Washington Virology Research Clinic, Seattle, Washington 98122, United States

Last updated: June 23, 2005